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BioAgilytix

Manager I - Large Molecule (LC/MS)

BioAgilytix, Durham, North Carolina, United States, 27703

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At BioAgilytix, we are passionate about premier science and the impact it has on our world. Our team of highly experienced scientists and professionals deliver tailored services for supporting new medicine breakthroughs with best-in-class bioanalytical services. We are tirelessly committed to our customers by being solution-oriented and deadline-driven. . . and we are growing. Our culture is fast-paced, fun and never boring. Because we work across numerous clients and drug modalities, your career can develop rapidly. You’ll gain experience with a variety of challenges all while you enable life-changing, life-saving therapeutics to the patients who need them.

Our Liquid Chromatography/Mass Spectrometry (LC/MS) team is seeking a Manager I to serve as Bioanalytical Project Manager (BPM)/Principal Investigator (PI), overseeing all aspects of bioanalytical studies—including project scope definition, proposal preparation, timelines, scheduling, budget, and revenue management. This role is best suited for someone with deep expertise in method development, GxP-compliant validation, and both targeted and untargeted analysis using chromatography and mass spectrometry, combined with strong communication skills and the confidence to engage with external clients.

At our organization, we’re dedicated to pushing the boundaries of analytical science. Our LC/MS team leverages the synergy between liquid chromatography (LC) and mass spectrometry (MS) to revolutionize how we understand and quantify compounds in complex samples. With a steadfast commitment to excellence and innovation, we tackle challenges across the spectrum of drug discovery to clinical diagnostics, driving advancements that shape the future of healthcare.

Essential Responsibilities

Lead team(s) developing and validating LC/MS bioanalytical assays for support of preclinical, clinical and product release studies.

Motivating team by inspiring employees to achieve goals and aligning employee goals with company strategy by understanding trends and operations, managing departmental budgets and resources, and being the expert in using tools/software relevant to the team.

Work closely with clients to assure successful on time execution of assays, validation, and sample analysis under GxPs.

Prioritizing tasks and managing schedules efficiently.

Meet regularly with lab management to ensure instrument resources and employees are utilized effectively across all teams.

Responsible for team performance and outcomes.

Leading teams through transitions and new initiatives.

Design and execute experiments efficiently and assign tasks appropriately to employees based on skills.

Anticipating and mitigating potential problems and handling disputes calmly and fairly

Present data and posters.

Conduct group team meetings to understand employee’s input and concerns, give constructive and timely feedback, and implement 1:1 meetings with employees on a regular basis.

Hiring and building a team that is knowledgeable and cooperative by investing in the employees’ professional growth, setting goals and evaluating results.

Identify new analytical techniques and technologies and lead their implementation.

Review analytical instrument and equipment calibration, qualification and maintenance records.

Perform statistical analysis.

Write and review reports and prepare SOPs.

Lead regularly scheduled client meetings to ensure effective communication and manage client expectations.

Provide client satisfaction and great science.

Achieve corporate revenue targets.

Additional Responsibilities

Other duties as needed

Minimum Preferred Qualifications - Education/Experience

Bachelor’s degree in molecular biology, biochemistry, immunology, biotechnology, or related field with not less than 12 years’ experience in a scientific laboratory environment; or

Master’s degree in molecular biology, biochemistry, immunology, biotechnology, or related field with not less than ten (10) years’ experience in a scientific laboratory environment; or

PhD in molecular biology, biochemistry, immunology, biotechnology, or related field with not less than eight (8) years’ experience in a scientific laboratory environment

Knowledge of regulatory guidance and industry best practices for LC/MS, and other large molecule assays

Demonstrated expertise in developing chromatographic and mass spectrometric assays including LC/MS and LC/MS/MS for bioanalytical studies by extracting analytes of interest from complex biological matrices using protein precipitation, liquid-liquid, solid phase, immunoprecipitation or other extraction technique

Advanced capabilities in data analysis, data visualization statistical analysis

Microsoft Word, Excel, Sciex OS/Analyst, MassLynx, XCalibur, Chromeleon, Watson LIMS, JMP, Graphpad Prism

GDP, GLP, GCLP, GCP

Minimum Preferred Qualifications - Skills

Expertise in development, validation and execution of chromatographic and mass spectrometric assays (LC/MS), and/or ability to perform most tasks associated with custom research planning and bench work

Demonstrated experience in a supervisory role leading teams to meet objectives while adapting to competing demands, tight deadlines, and a fast-paced environment

Must work effectively within team to meet objectives under time constraints

A knack for designing efficient and impactful experiments

Experience working in a regulated environment, with a thorough understating of GDP, GLP, GCLP, GCP

Independence, enthusiasm, openness, and adaptability

Demonstrated effective communication skills

The ability to inspire others to do their best work and drive results

Excellent customer service skills (internal and external)

Working Environment

Primarily office environment

Occasional laboratory environment

Exposure to biological fluids with potential exposure to infectious organisms

Rare exposure to skin and lung irritants, toxic materials, and hazardous waste

Personal protective equipment required, such as protective eyewear, garments, and gloves

Routinely uses standard office equipment such as computers, phones, photocopiers, and filing cabinets

Supervisory Responsibility

This position supervises Analyst I/II/III and Scientist I/II/III

Ability to guide and direct others in successful outcomes and provide mentorship

Performance reviews/evaluations and career development of staff

Physical Demands

Ability to work in an upright and/or stationary position for up to eight (8) hours per day

Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists to operate lab equipment

Frequent mobility needed

Frequent crouching, stooping, with frequent bending and twisting of upper body and neck

Light to moderate lifting and carrying (or otherwise moves) objects including laboratory equipment, laboratory supplies, and laptop computer with a maximum lift of 20 pounds

Ability to access and use a variety of computer software

Ability to communicate information and ideas so others will understand, with the ability to listen to and understand information and ideas presented through spoken words and sentences

Frequently interacts with others to obtain or relate information to diverse groups

Requires multiple periods of intense concentration

Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence

Ability to perform under stress and multi-task

Regular and consistent attendance

Position Type and Expected Hours of Work

This is a full-time position

Some flexibility in hours is allowed, but the employee must be available during the “core” work hours as published in the BioAgilytix Employee Handbook

Occasional weekend, holiday, and evening work required

Occasional travel required

BENEFITS AND OTHER PERKS Medical Insurance (HDHP with HSA; PPO), Dental Insurance, Vision Insurance, Flexible Spending Account (medical; dependent care), Short Term Disability | Long Term Disability Life Insurance, Paid Time Off (4 weeks per year), Parental Leave, Paid Holidays (9 scheduled; 5 floating), 401k with Employer Match, Employee Referral Program

COMMITMENT TO EQUAL OPPORTUNITY BioAgilytix provides equal employment opportunities to all employees and applicants for employment without regard to race, color, ancestry, national origin, gender, sexual orientation, marital status, religion, age, disability, gender identity, results of genetic testing, service in the military, or any other group protected by federal, state, or local law.

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